Ryota Nishio, Hirotoshi Watanabe, Takeshi Morimoto, Masahiro Natsuaki, Ko Yamamoto, Yuki Obayashi, Ryusuke Nishikawa, Tomoya Kimura, Manabu Ogita, Hideki Wada, Hirohisa Endo, Jun Shitara, Kenji Ando, Takenori Domei, Tsuyoshi Isawa, Hiroyuki Takenaka, Takashi Yamamoto, Tetsuya Ishikawa, Itaru Hisauchi, Hideo Tokuyama, Hiroki Sakamoto, Takanari Fujita, Mamoru Nanasato, Hideki Okayama, Satoru Suwa, Koh Ono, Takeshi Kimura, STOPDAPT-3 Investigators
There was no interaction for bleeding between PPI prescription and antiplatelet regimen, but a significant interaction for cardiovascular events, requiring cautious interpretation due to the small no-PPI subgroup and baseline imbalances.
BACKGROUND: There are no previous reports exploring the interaction of proton-pump inhibitors (PPI) on the early effect of aspirin-free strategy compared with dual antiplatelet therapy (DAPT) after PCI.
METHODS AND RESULTS: Among 5,654 patients who were discharged alive within 30 days after randomization in ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 (STOPDAPT-3), 4,958 patients received PPI prescriptions (PPI subgroup; no-aspirin group, n=2,356; and DAPT group, n=2,602), and 696 patients did not (no-PPI subgroup; no-aspirin group, n=482; and DAPT group, n=214). The co-primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding, and the co-primary cardiovascular endpoint was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke. No significant interaction was observed between PPI prescription and antiplatelet regimen on the bleeding endpoint (PPI: hazard ratio [HR] 0.90; 95% confidence interval [CI] 0.66-1.22; no-PPI: HR 0.52; 95% CI 0.17-1.54; P interaction=0.34). For the cardiovascular endpoint, there was a lower risk of no aspirin relative to DAPT in the no PPI subgroup (0.41% vs. 3.27%; HR 0.13; 95% CI 0.03-0.60), but not in the PPI subgroup (HR 1.29; 95% CI 0.86-1.93) with a significant interaction (P interaction=0.005).
CONCLUSIONS: There was no interaction for bleeding between PPI prescription and antiplatelet regimen, but a significant interaction for cardiovascular events, requiring cautious interpretation due to the small no-PPI subgroup and baseline imbalances.